MDMA for AUD/PTSD Comorbidity

Summary

The study investigators are conducting the first open label pilot trial of MDMA-assisted therapy (MDMA-AT) with a comorbid sample of military veterans with a comorbid diagnosis of Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD). This novel experimental treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA HCl, along with non-drug preparatory and integrative therapy. The Primary Outcome measure, the Timeline Follow-back (TLFB), will evaluate changes in alcohol use over time. Changes in PTSD symptoms will also be evaluated.

Timeline

Start

2024-02-06

Primary completion

2026-01-21

Completion

2026-01-30

Publications

• Eaton E, Capone C, Gully BJ, Brown ZE, Monnig M, Worden MS, Swift RM, Haass-Koffler CL. Design and methodology of the first open-label trial of MDMA-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder: Considerations for a randomized controlled trial. Contemp Clin Trials Commun. 2024 Jul 20;41:101333. doi: 10.1016/j.conctc.2024.101333. eCollection 2024 Oct.

Drugs

Indications